Clinical Research Associate (Part Time)

- Clinical monitoring and site-coordination / management
- Initially responsible for overall conduct of a single clinical trial site in Singapore
- Establish and maintain primary communication with clinical site and with Sponsor   and/or CRO.
- Acts as Sponsor/CRO liaison to resolve any site related issues quickly and effectively.
- Monitoring the assigned clinical trial following company SOPs and in accordance with GCP ICH and ISO 14155.
- Independently conducts ongoing (interim) and close-out monitoring visits
- Conducts site initiation visit in collaboration with Sponsor/CRO
- Co-ordinates the initial and ongoing review and collection of “essential”, regulatory documents.
- Maintain project files including: ethics committee approvals; curricula vitae of investigators and study personnel; clinical investigators brochure; protocols; case report forms instructions; consent documents etc
- Review/Monitor SAEs and ensure that they are reported according to protocol, ethical, regulatory and company guidelines and SOPs.
- Track milestones and prepare and submit monitoring reports and other reports as required
- Assist in investigator and study staff training.
- Participate in global conference calls and meetings to review progress of ongoing clinical trial
- May be called on to participate in business development activities (promotion) of CRO in Singapore

- Degree in Science / Health related field
- At least 2 – 3 years clinical research experience in pharmaceutical, biotech or CRO setting with a minimum of 2 years of independent clinical monitoring experience
- Relevant industry experience (preferably with medical devices) in the areas described above and have a good understanding or exposure to ICH/GCP, ISO14155 and/or ISO13485
- Good speaking / written English